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N/A N=27 Other

Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

Healthy

Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: SpO2 ARMS of Sensor Under Motion Conditions — 1.31 % of oxygen saturated hemoglobin

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
RD Disposable Sensors (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Masimo Corporation
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
SpO2 ARMS of Sensor Under Motion Conditions
1.31

Summary

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Eligibility Criteria

Inclusion Criteria

  • Competent non-smoking adults
  • Must weigh a minimum of 110 pounds and no more than 250 pounds unless subject is over 6 feet tall.
  • Subjects must understand and consent to be in the study.
  • American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
  • Subjects with hemoglobin greater than or equal to 11 g/dL.

Exclusion Criteria

  • Subjects with polished, gel or acrylic nails.
  • Subjects with damaged and/or finger nail deformities.
  • Subjects who have had caffeine consumption the day of the study.
  • Subjects who have taken pain medication 24 hours before the study.
  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks.
  • Subjects who smoke.
  • Subjects who use recreational drugs.
  • Subjects who are pregnant or nursing.
  • Subjects having either signs or history of peripheral ischemia.
  • Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
  • Subjects with psychiatric conditions or are on psychiatric medications.
  • Subjects who have had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ears, nose throat (ENT) surgery, joint replacement or gynecological surgeries.
  • Subjects who have had minor surgery or conditions in the past two months including but not limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma donation, skin biopsy/ procedures, root canal, fractures, eye surgery, and other minor procedures.
  • Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest congestion will have a 2 week waiting period from the time of finishing medications or must have no more symptoms.
  • Subjects with claustrophobia, or anxiety.
  • Subjects who have been in severe car accidents or a similar type of accidents will have a 12 month waiting period, from the time of the accident.
  • Subjects who have had a concussion will have a 12 month waiting period, from the time of the concussion.
  • Subjects with chronic unresolved asthma, lung disease and respiratory disease. Allergies to lidocaine, latex, adhesives, or plastic.
  • Subjects with finger deformities or injuries (specific finger will not be used).
  • Subjects with heart conditions, diabetes or hypertension.
  • Subjects with resting heart rates greater than 85 beats per minute (BPM) or below 45 BPM
  • Subjects who have given birth naturally will have 6 month waiting period. Subjects who had a pregnancy terminated, a miscarriage or had a c-section will have a 12 month waiting period.
  • Others deemed ineligible by the clinical staff.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03124784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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